510(k) K212641

StrataMR II Valves and Shunts by Medtronic Neurosurgery — Product Code JXG

K212641 is an FDA 510(k) premarket notification submitted by Medtronic Neurosurgery for the device "StrataMR II Valves and Shunts". The FDA issued a decision of Substantially Equivalent on September 16, 2021. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Medtronic Neurosurgery has at least 10 other 510(k) clearances on record.